Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
1 other identifier
interventional
2
1 country
1
Brief Summary
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedStudy Start
First participant enrolled
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedJanuary 20, 2025
January 1, 2025
2 months
August 2, 2022
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Ocular safety
Incidence of ocular treatment emergent adverse events (TEAEs)
Over 28 days
Systemic safety
Incidence of systemic TEAEs
Over 28 days
Secondary Outcomes (1)
Ocular hypotensive effectiveness
28 days
Study Arms (1)
QLS-101, 2.0%
EXPERIMENTALQlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Interventions
ophthalmic solution in a single use dropper vial
Eligibility Criteria
You may qualify if:
- Between 12 and 19 years of age at Screening.
- Diagnosed with SWS
- Elevated IOP
- Willing to continue current dosing regimen of IOP-lowering medications
- Able to provide informed consent and follow study instructions
You may not qualify if:
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type 4 months prior to study
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye
- History of or active clinically significant ocular disease
- Use of topical ocular corticosteroids in the 6 weeks prior to study
- Patient cannot be applanated or tolerate IOP measurements
- Patient is pregnant or lactating
- Uncontrolled systemic disease that can interfere with study participation
- Inability to self-dose or identify a caregiver for all study eye drop administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qlaris Bio, Inc.lead
Study Sites (1)
Duke Eye Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Freedman, M.D.
Duke Eye Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2022
First Posted
August 10, 2022
Study Start
November 23, 2022
Primary Completion
January 25, 2023
Study Completion
March 20, 2023
Last Updated
January 20, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share